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Administrative data

Description of key information

Eye irritation: not irritating (OECD 405; GLP)

Skin irritation: not irritating (OECD 404, GLP, read across to structural analogue)

No skin irritation study with fatty acids, C8-10, zinc salts is available, thus the skin irritation potential will be addressed with existing data on a structural analogue shorter-chained fatty acid (C8) zinc salt representing the lower chain lenght (C8) of substance Fatty acids, C8-10, zinc salts.

Respiratory irritation: not irritating (OECD 436, GLP, read across to structural analogue)

Results of the histopathological examination of lung tissue acutely exposed to the structural analogue (zinc dilaurate; C12) via inhalation (OECD 436 test) do not indicate an irritative potential to the respiratory tract. Furthermore, key studies on skin and eye irritation demonstrate a lack of irritation/corrosion potential.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992-10-20 to 1992-10-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1981-05-12
GLP compliance:
yes
Species:
rabbit
Strain:
other: Kleinrussen, CHbb:HM
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Thomae GmbH, Biberach/D.
- Age at study initiation: approx. 9 months
- Weight at study initiation: approx. 2590 g
- Housing: individual accommodation
- Diet (ad libitum): Ssniff rabbit diet K4 (Ssniff GmbH, Soest/D, Batch: 770992/09)
- Water (ad libitum): tap water
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: approx. 20-25 °C
- Relative humidity: approx. 45-70 %
- Air changes: at least eight per hour
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): the undiluted test substance Stabiol VZN 1950 was applied at the dose level of 0.5 g per animal.
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after exposure
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: the flank of each experimental animal was sheared approx. 24 hours prior to the application with an electric clipper. Animals with intact and healthy skin were used in the test.
The semi-occlusive exposure was performed by means of a 6 cm^2 adhesive air- and vapour permeable gauze-patch which was fixed by a hypoallergic adhesive gauze-bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the exposure was terminated after four hours by removing the patch and cleaning the relevant skin from the residual test substance.

SCORING SYSTEM: according to Draize scale
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No dermal effects were observed at all experimental animals up to 72 hours after exposure.
Interpretation of results:
GHS criteria not met
Conclusions:
Stabiol VZN 1950 is not irritating to the skin.
According to the EC-Regulation 1272/2008, the test item is not classified as skin irritant.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-01-13 to 2012-01-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
2008-05-30
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 2002-04-24
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
signed: 2009-11-12
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS:
- Source: LPT Laboratory of Pharmacology and Toxicology GmbH Co. KG, Branch Löhndorf, 24601 Löhndorf/Post Wankendorf, Germany
- Age at study initiation: approx. 7.5- 8.5 months
- Weight at study initiation: 2.7 - 2.9 g
- Housing: for 8 hours following test item application, the animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn, wiping of the eyes with the paws and excluded irritation of the eye by excrements and urine.
During the acclimatisation period and after the 8-hour period in restrainers, the animals were kept singly in cages with dimensions of 380 mm x 425 mm x 600 mm (manufacturer: Dipl.Ing. W. EHRET GmbH, 16352 Schönwalde, Germany)
- Diet (ad libitum): commercial diet, ssniff® K-H V2333 (Ssniff Spezialdiäten GmbH, 59494 Soest, Germany
- Water (ad libitum before and after the exposure period): tap water
- Acclimation period: at least 20 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature: 20°C ± 3°C (maximum range)
- Relative humidity: 30% - 70% (maximum range; aim was 50% - 60%)
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of the test item were administered into one eye each of three animals. The volume of particulates was measured after gently compacting them, e.g. by tapping the measuring container.
The test item was placed into the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control.
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
1, 24, 48 and 72 hours after the administration
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
In accordance with the OECD 405 guideline the test was performed initially using one animal. As no corrosive or severe irritant effects were observed in this animal, 2 further animals were employed 24 hours after start of the initial test.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eyes were rinsed with portions of 20 mL 0.9% aqueous NaCl solution, each.
- Time after start of exposure: 1 hour after administration

SCORING SYSTEM: according to the Draize scale
Any further lesions are listed.
Body weight of all animals was measured at the beginning of the study. Behaviour and food consumption were monitored.

TOOL USED TO ASSESS SCORE: the eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48 and 72 hours after the administration. The eye reactions were observed and registered.
24 hours after administration, fluorescein (Fluorescein SE Thilo drops (ALCON PHARMA GmbH, 79108 Freiburg, Germany)) was applied to the eyes before being examined to aid evaluation of the cornea for possible lesions.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 24 hour fluorescein test: corneal staining (1/4 to 1/2 of the surface)
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: Conjunctival redness (grade 1) was observed at the 60 minute observation in animal #2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Corneal opacity (grade 1 or 2) was observed in one animal 24 and 48 hours after the instillation.
The fluorescein test performed 24 hours after the instillation revealed corneal staining in one animal (1/4 to 1/2 of the surface).
Irritation of the iris (grade 1) was observed in one animal 24 and 48 hours after the instillation.
Conjunctival redness (grade 1) was observed in one animal 60 minutes and in another animal 60 minutes to 48 hours after the instillation.
Chemosis (grade 1) was observed in one animal 24 hours after the instillation.
The effects observed were fully reversible within 72 hours.
Other effects:
There were no systemic intolerance reactions.
Interpretation of results:
GHS criteria not met
Conclusions:
The test material is non-irritating to the eyes.
According to the EC Regulation No. 1272/2008, the substance is not classified as an eye irritant.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Fatty acids, C8-10, zinc salts

Fatty acids, C8 -10, zinc salts is not irritating to the eye and not expected to be irritating to the skin based on the lack of skin irritation potential of a zinc salt of a short-chained fatty acid (C8) representing the lower chain length (C8) of substance Fatty acids, C8-10, zinc salts, and in addition with a higher zinc content. Results of the histopathological examination of lung tissue acutely exposed to the structural analogue zinc dilaurate via inhalation (OECD 436 test) do not indicate an irritative potential to the respiratory tract.Further testing is not required

Justification for classification or non-classification

By substance specific in vivo data on eye irritation and read-across of in vivo skin and respiratory irritation / corrosion data on structural analogue fatty acid(s), zinc salts, substance Fatty acids, C8-10, zinc salts is not expected to have an eye, skin or respiratory tract irritation or corrosion potential.

According to the criteria ofregulation (EC) 1272/2008 and its subsequent amendments, substance Fatty acids, C8-10, zinc salts does not have to be classified and has no obligatory labelling requirement for skin, eye or respiratory irritation.

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